Developing a strong corrective and preventive action (CAPA) process is critical for producing quality product. The ability to determine the root cause of a problem and then eliminate potential recurrence is a hallmark of a strong quality system. FDA investigators will evaluate a firm’s CAPA processes to ensure they are effective.

CAPAs Part of a Risk-Based Approach

But not every event should trigger a CAPA. When an issue occurs, such as a deviation or nonconformance, an investigation must be conducted to identify root cause. Phamatech Associates’ Stephanie Gaulding writes that “deviation systems should also be built to triage events into risk-based categories with sufficient time allocated to each category to drive risk-based investigations and focus the most time and effort on the highest risk and most complex events.”

In other words, it should be a risk-based process.

When an investigation is inadequate, problems that should have been addressed with a CAPA can recur. FDA investigator Ileana Barreto-Pettit described how one company’s failure to sufficiently identify root cause resulted in further risks involving a malfunctioning autoclave. The investigation into the autoclave began a month prior to an FDA inspection and was still ongoing at the time of inspection. The autoclave was also still being used. This resulted in 483 observations and a warning letter.

The warning letter included language that the company’s CAPA plan provides for measures to ensure promptly detecting issues with equipment and processes for execution of repairs, preventive maintenance schedules, and equipment upgrades.

What FDA Investigators Are Looking at When it Comes to CAPAs

One of the most common citations over the past 30 years involves batch failure investigations, according to FDA Director for the Division of International Drug Quality Carmelo Rosa. At the 2021 PDA/FDA Joint Regulatory Conference, he stated, “because we continue to see it, it just leads us to the conclusion that there is something missing in that quality system that has been unable to identify the root causes or to systemically improve problems related to the corrective actions implemented.”

When it comes to medical devices, FDA’s Liza Garcia noted that all CAPA activities need to be documented as per 820.100(b). During the 2021 FDA/Xavier MedCon conference she explained that investigators also evaluate if a firm has selected a verification method to capture the recurrence of an issue. This is a crucial part of ensuring that issues do not recur.

Another CAPA-related issue that investigators observe involves failure to investigate special cause variations and lack of feedback on the CAPA process.

Not all quality issues require CAPAs. CAPAs should be triggered following robust investigations into deviations and non-conformances that fully identify root cause using a risk-based approach.